FDA WARNING_LETTER - Illumivaption Inc. d/b/a Nashville Vapor - August 10, 2023

The FDA issued a Warning Letter to Illumivaption Inc. d/b/a Nashville Vapor on August 10, 2023, following a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Enter the Dragon" was cited as a new tobacco product not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided.

The letter emphasizes that marketing such products without authorization is a prohibited act under sections 301(k) and 301(p) of the FD&C Act. The FDA requires the company to promptly address these violations and ensure all tobacco products comply with the FD&C Act and implementing regulations. Failure to comply may result in regulatory actions including civil money penalties, seizure, and/or injunction.

Illumivaption Inc. must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale/distribution of non-compliant products, and outlining